Pen needle tip

ABSTRACT

A needle tip assembly includes a needle tip, a needle tip cover structured and arranged to facilitate installation of the needle tip onto at least one of a pen needle, a pre-loaded syringe, and an injection device, and a slot arranged on a sidewall of a body of the needle tip. This Abstract is not intended to define the invention disclosed in the specification, nor intended to limit the scope of the invention in any way.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. application Ser. No.12/963,678 filed Dec. 9, 2010, which application is a continuation ofU.S. application Ser. No. 11/616,195 filed Dec. 26, 2006. The disclosureof each of these applications is/are expressly incorporated by referenceherein in its/their entireties.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to pen needles, e.g., pre-loadedsyringes, such are utilized for injection of medicament into the bodytissues of human and animal patients. More specifically, this inventionrelates to a pen needle having a removable tip which can be preventedfrom reuse and/or which utilizes one or more mechanisms for preventingthe possibility of inadvertent needle pricks.

This invention also relates to pen needle tips for pen needles whereinthe pen needle tip is configured to prevent it from being re-used.

This invention also relates to tips for devices such as, e.g.,pre-loaded syringes, which can be used only once, i.e., single-use tips,and/or to tips which include one or more mechanisms for preventing theuser from being pricked when handling the tip.

2. Discussion of Background Information

U.S. Pat. No. 4,973,318, the disclosure of which is hereby expresslyincorporated by reference in its entirety, discloses a disposablesyringe includes first and second housing elements which are coupledtogether for rotation without axial movement therebetween. The firsthousing element receives a cartridge of a solution to be injected, andmounts a liquid outlet needle at its front end. A piston rod is disposedin the second housing element to move axially therein, and this pistonrod includes a rod element and a nut element. The rod element is coupledto the first housing element to move axially therein without relativerotation therewith, and the nut element is threaded to the rod elementfor telescoping movement therewith and is configured to move axially inthe second housing element without relative rotation therein. A pressurereceiving element is mounted on the nut element. The housing, rod, nutand pressure receiving elements cooperate such that relative rotationbetween the housing elements in a selected direction causes relativerotation between the nut and rod elements and thereby increases theeffective length of the piston rod and causes the pressure receivingelement to extend from the second housing element. A protective cap isremovably mounted over the first housing element and is configured toabut second housing element while mounted in place on the first housingelement. This protective cap is engaged with the first housing elementsuch that rotation of the cap with respect to the second housing elementcauses rotation of the first housing element with respect to the secondhousing element.

This type of syringe is shown in FIGS. 1-7 wherein the pre-loadedsyringe 1 has a proximal threaded end 2 which is configured to accept aneedle tip assembly consisting of a needle tip 5, a needle tip cover 3,and a needle cover 4. As is evident from FIGS. 2 and 3, a user installsthe needle tip assembly 3/4/5, after removing the assembly from itsindividual package, onto the threaded proximal end 2 by simply slidingit onto the end 2 axially. Because internal threads of the needle tip 5are mounted to radially deflectable members, installation over threadsof the end 2 occurs with a ratchet effect. This installation is madesafe by the covers 4 and 5 which ensure that the user will not bepricked by the needle N. Once installed, the user can remove the needletip cover 3 by simply sliding it off axially as is shown in FIG. 4.Next, as shown in FIG. 5, the user can remove the needle cover 4 toexpose the needle N. The pen needle device then assumes the positionshown in FIG. 6 and is made ready for use in providing an injection tothe user. After injection, the user will typically remove the needle tip5 and discard the same. To accomplish the removal, the user willtypically reinstall the needle tip cover 3 and rotate it to cause theneedle tip to unthread from the threaded end 2 (some users may eveninstall the needle cover 4 prior to installing the cover 3). Onceremoved, however, it is still possible to reinstall the used needle tip5 by simply repeating the steps noted above. FIG. 7 illustrates that theneedle tip 5 can even be installed without the needle covers 3 and 4.Unless the user discards the needle tip 5, it is possible that she orother users will not remember or know that it has already been used.That is, there is nothing to prevent reuse of the needle tip 5 shouldsomeone attempt to reinstall the needle tip onto the end 2. Furthermore,if the user is unable to locate the covers 3 and 4 (i.e., if they havebecome lost), she must then attempt to grip the needle tip 5 in order tounthread it from the end 2. As is apparent, this action can be riskybecause the user can possibly inadvertently be pricked by the needle Neither in attempting to properly grip the needle tip 5, in the action ofrotating it to the point it is removed, or even in the handling of theneedle tip 5 after it has been removed and prior to being properlydiscarded. Still further, if the needle tip 5 is not properly discarded(such as being correctly placed in a sharps container), others may comein contact with the needle tip 5 and possibly become injured thereby.

It is therefore desirable to provide a pen needle system which is saferto use compared to the conventional devices discussed above and/or whichdoes not have one or more of the above-noted disadvantageous.

SUMMARY OF THE INVENTION

According to one non-limiting embodiment of the invention, there isprovided a pen needle having a removable tip which can be prevented fromreuse and/or which utilizes one or more mechanisms for preventing thepossibility of inadvertent needle pricks.

According to another non-limiting embodiment of the invention, there isprovided a pen needle tip for a pen needle wherein the pen needle tip isconfigured to prevent it from being re-used.

According to another non-limiting embodiment of the invention, there isprovided a needle tip for a device such as, e.g., a pre-loaded syringe,which can be used only once, i.e., single-use tips, and/or to tips whichinclude one or more mechanisms for preventing the user from beingpricked when handling the tip.

According to another non-limiting embodiment of the invention, there isprovided a pre-loaded syringe or pen needle injection device tipassembly comprising a needle tip comprising a body and a needle having afirst puncturing end projecting out beyond a forward end of the body anda second puncturing end projecting into an interior space of the body.The interior space of the body is sized and configured to receivetherein one end of the pre-loaded syringe or the pen needle injectiondevice. A generally cylindrical sidewall of the body includes a slotoriented parallel to the needle. The second puncturing end being sizedand configured to extend into the one end when the body is installed onthe one end. The needle tip is structured and arranged to be removablyconnected to the one end of the pre-loaded syringe or the pen needleinjection device.

According to another non-limiting embodiment of the invention, there isprovided a needle tip assembly comprising a needle tip, a needle tipcover structured and arranged to facilitate installation of the needletip onto at least one of a pen needle, a pre-loaded syringe, and aninjection device, and at least one of an arrangement for preventingre-installation or re-use of the needle tip, a safety mechanism coupledto the needle tip via a living hinge, and a safety cover non-removablycoupled to the needle tip.

The arrangement may comprise a ring which is moveble from a firstposition to a second position. The arrangement may comprise a ring whichis axially moveble. The arrangement may comprise a locking member whichis moveble from an unlocked position to a locked position. Thearrangement may comprise a movable member mounted to a body of theneedle tip, wherein the movable member is axially moveble from a firstposition to a second position by the needle tip cover. The arrangementmay comprise a movable member mounted to a body of the needle tip,wherein the movable member is axially moveble from a first position to asecond position, and wherein, when in the second position, the needletip is prevented from being re-installed. The arrangement may comprisean elastic member mounted to a body of the needle tip, wherein theelastic member is moveble from a first position to a second position,and wherein, when in the second position, the needle tip is preventedfrom being re-installed. The arrangement may comprise at least oneinwardly projecting member adapted to be deflected inwardly. The atleast one inwardly projecting member may be biased away from inwarddeflection. The arrangement may further comprise a ring which is moveblefrom a first position to a second position causing inward deflection ofthe at least one inwardly projecting member. The arrangement may furthercomprise a ring which is axially moveble to a position causing inwarddeflection of the at least one inwardly projecting member. Thearrangement may further comprise a locking member which is moveble froman unlocked position to a locked position causing inward deflection ofthe at least one inwardly projecting member. The arrangement may furthercomprise a movable member mounted to a body of the needle tip, whereinthe movable member is axially moveble from a first position to a secondposition by the needle tip cover, whereby the second position causesinward deflection of the at least one inwardly projecting member. Thearrangement may further comprise a movable member mounted to a body ofthe needle tip, wherein the movable member is axially moveble from afirst position to a second position, and wherein, when in the secondposition, the needle tip is prevented from being re-installed by inwarddeflection of the at least one inwardly projecting member. Thearrangement may further comprise an elastic member mounted to a body ofthe needle tip, wherein the elastic member is moveble from a firstposition to a second position, and wherein, when in the second position,the needle tip is prevented from being re-installed by inward deflectionof the at least one inwardly projecting member. The safety mechanism maycomprise a proximal needle cover. The safety mechanism may comprise amember which covers a distal end of the needle tip. The safety cover maycomprise a proximal needle cover. The safety cover may comprise a memberwhich covers a distal end of the needle tip. The needle tip cover may bestructured and arranged to facilitate removal of the needle tip from theat least one of the pen needle, the pre-loaded syringe, and theinjection device.

According to another non-limiting embodiment of the invention, there isprovided a needle tip assembly comprising a needle tip comprising a bodyand a needle projecting from the body and a needle tip cover structuredand arranged to facilitate installation of the needle tip onto at leastone of a pen needle, a pre-loaded syringe, and an injection device,wherein the needle tip cover activates an arrangement for preventingre-installation or re-use of the needle tip.

The assembly may further comprise at least one of a safety mechanismcoupled to the needle tip via a living hinge and a safety covernon-removably coupled to the needle tip. The needle tip cover may bestructured and arranged to facilitate removal of the needle tip from theat least one of the pen needle, the pre-loaded syringe, and theinjection device,

According to another non-limiting embodiment of the invention, there isprovided a needle tip assembly comprising a needle tip comprising abody, a needle projecting from the body, and at least one inwardlyprojecting member adapted to be deflected inwardly and a needle tipcover structured and arranged to facilitate installation of the needletip onto at least one of a pen needle, a pre-loaded syringe, and aninjection device, wherein, when the at least one inwardly projectingmember is deflected inwardly, the needle tip is prevented from beingre-installed.

The needle tip cover may activate an arrangement for preventingre-installation or re-use of the needle tip. The assembly may furthercomprise at least one of a safety mechanism coupled to the needle tipvia a living hinge and a safety cover non-removably coupled to theneedle tip. The needle tip cover may be structured and arranged tofacilitate removal of the needle tip from the at least one of the penneedle, the pre-loaded syringe, and the injection device. The assemblymay further comprise an arrangement that is moveble from a firstposition to a second position. The arrangement may comprise a ring whichis axially moveble. The arrangement may comprise a locking member whichis moveble from an unlocked position to a locked position. Thearrangement may comprise a movable member mounted to the body of theneedle tip, wherein the movable member is axially moveble from a firstposition to a second position by the needle tip cover. The arrangementmay comprise a movable member mounted to the body of the needle tip,wherein the movable member is axially moveble from a first position to asecond position, and wherein, when in the second position, the needletip is prevented from being re-installed. The arrangement may comprisean elastic member mounted to the body of the needle tip, wherein theelastic member is moveble from a first position to a second position,and wherein, when in the second position, the needle tip is preventedfrom being re-installed.

According to another non-limiting embodiment of the invention, there isprovided a method of using the needle tip assembly of the type describedabove, wherein the method comprises installing the needle tip assemblyonto a proximal end of an injection device, activating the arrangementbefore using the injection device, and re-installing the needle tipcover and removing the needle tip using the needle tip cover.

According to another non-limiting embodiment of the invention, there isprovided a method of using the needle tip assembly of the type describedabove, wherein the method comprises installing the needle tip assemblyonto a proximal end of an injection device, activating with the needletip cover, an arrangement for preventing re-installation or re-use ofthe needle tip, and re-installing the needle tip cover and removing theneedle tip using the needle tip cover.

According to another non-limiting embodiment of the invention, there isprovided a method of using the needle tip assembly of the type describedabove, wherein the method comprises installing the needle tip assemblyonto a proximal end of an injection device and re-installing the needletip cover and removing the needle tip using the needle tip cover,wherein after removal, the at least one inwardly projecting member isdeflected inwardly so as to prevent re-installation of the needle tip.

Other exemplary embodiments and advantages of the present invention maybe ascertained by reviewing the present disclosure and the accompanyingdrawing.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is further described in the detailed descriptionwhich follows, in reference to the noted plurality of drawings by way ofnon-limiting examples of exemplary embodiments of the present invention,in which like reference numerals represent similar parts throughout theseveral views of the drawings, and wherein:

FIG. 1 shows an enlarged partial side view of a proximal end of a priorart pen needle or pre-loaded syringe/injection device. The proximal endis shown with the cap removed and in a prior-use state, i.e., it isready to receive thereon a needle tip;

FIG. 2 shows the proximal end of FIG. 1 along with a prior art needletip assembly in a position prior to installation onto the proximal end.The needle tip cap and the needle cap are both shown in cross-section;

FIG. 3 shows the proximal end and prior art needle tip assembly of FIG.2 after installation of the needle tip assembly onto the proximal end;

FIG. 4 shows how the needle tip cap can be removed from the prior artneedle tip assembly of FIG. 3;

FIG. 5 shows how the needle cap can be removed from the prior art needletip of FIG. 4;

FIG. 6 shows the needle tip mounted onto the pen needle device in aposition ready for injection according to the prior art;

FIG. 7 shows the needle tip being removed from the pen needle deviceaccording to the prior art. This would occur after use and can occur byunthreading the needle tip from the threaded proximal end of the penneedle device. The arrow illustrates that it is possible to re-installthe needle tip onto the threaded proximal end of the pen needle device;

FIG. 8 shows the proximal end of FIG. 1 along with a needle tip assemblyaccording to one embodiment of the invention. The needle tip assembly isshown in a position prior to installation onto the proximal end. Theneedle tip is shown in partial cross-section while the needle tip capand the needle cap are shown in cross-section;

FIG. 9 shows the needle tip assembly of FIG. 8 after installation ontothe proximal end;

FIG. 10 shows the needle tip assembly of FIG. 9 after the needle tip capis moved axially to a position which causes a ring to move to a lockedposition;

FIG. 11 shows the needle tip assembly of FIG. 10 as the needle tip capis removed;

FIG. 12 shows the needle tip assembly of FIG. 11 as the needle cap isremoved;

FIG. 13 shows the pen needle device with the installed needle tip ofFIG. 12 in a position that is ready for injection. In this position, thering has been moved to the locked position which has caused a pluralityof inwardly deflecting members to engage the threaded proximal end ofthe pen needle device;

FIG. 14 shows the needle tip and proximal end of FIG. 13 after or as theneedle tip is removed from the proximal end. As is evident from FIG. 14,because the ring has been moved to the locked position and caused aplurality of inwardly deflecting members to engage the threaded proximalend of the pen needle device, when the needle tip is removed, theseinwardly deflecting members move inwardly to the point wherein they willinterfere with and/or prevent re-installation of the needle tip;

FIG. 15 shows how the inwardly deflecting members interfere with and/orprevent re-installation of the needle tip, i.e., the inwardly orientedprojections do not threadably engage with the threads of the proximalend and function to, in effect, reduce a diameter of the distal openingof the needle tip to the point that it is smaller than the outerdiameter of the proximal end;

FIG. 16 shows a distal end view of the needle cap which can be used inthe needle tip assembly according to the invention;

FIG. 17 shows a side cross-section view of the needle cap of FIG. 16;

FIG. 18 shows a distal end view of the needle tip cap which can be usedin the needle tip assembly according to the invention;

FIG. 19 shows a side cross-section view of the needle tip cap of FIG.18;

FIG. 20 shows the proximal end of FIG. 1 along with a needle tipassembly according to another embodiment of the invention. The needletip assembly is shown in a position prior to installation onto theproximal end. The needle tip is shown in partial cross-section while theneedle tip cap and the needle cap are shown in cross-section;

FIG. 21 shows the needle tip assembly of FIG. 20 after installation ontothe proximal end;

FIG. 22 shows the needle tip assembly of FIG. 21 after the needle tipcap is moved axially to a position which causes a ring to move to alocked position;

FIG. 23 shows the needle tip assembly of FIG. 22 as the needle tip capis removed;

FIG. 24 shows the needle tip assembly of FIG. 23 as the needle cap isremoved;

FIG. 25 shows the pen needle device with the installed needle tip ofFIG. 24 in a position that is ready for injection. In this position, thering has been moved to the locked position which has caused a pluralityof inwardly deflecting members to engage the threaded proximal end ofthe pen needle device;

FIG. 26 shows the needle tip and proximal end of FIG. 25 as the needletip is removed from the proximal end. Unlike the previous embodimentwhich utilizes internal threads arranged within the needle tip tothreadably engage with the treads of the proximal end of the pen needledevice, this embodiment relies upon a threaded engagement between theinwardly projecting members and the threaded proximal end of the penneedle device for removal of the needle tip. As is evident from FIG. 26,because the ring has been moved to the locked position and caused aplurality of inwardly deflecting members to engage the threaded proximalend of the pen needle device, when the needle tip is removed, theseinwardly deflecting members move inwardly to the point wherein they willinterfere with and/or prevent re-installation of the needle tip;

FIG. 27 shows the needle tip and proximal end of FIG. 26 after theneedle tip is removed from the proximal end;

FIG. 28 shows how the inwardly deflecting members interfere with and/orprevent re-installation of the needle tip, i.e., the inwardly orientedprojections have deflected inwardly to the point that they can no longerthreadably engage with the threads of the proximal end and function to,in effect, reduce a diameter of the distal opening of the needle tip tothe point that it is smaller than the outer diameter of the proximalend;

FIG. 29 shows a distal end of another needle tip which can be used inthe embodiment of FIGS. 20-28. The lock ring has been removed forpurposes of clarity. Unlike the embodiment of FIGS. 20-28 which utilizestwo oppositely arranged inwardly deflecting members, this embodimentutilizes four equally spaced inwardly projecting members. As is evidentfrom FIG. 29, the inwardly oriented projections have deflected inwardlyto the point that they, in effect, reduce a diameter of the distalopening of the needle tip so that it is smaller than the outer diameterof the proximal end;

FIG. 30 shows a side partial cross-section view of the needle tip ofFIG. 29;

FIG. 31 shows a cross-section view of the ring which can be used in theembodiments shown in FIGS. 8-30;

FIG. 32 shows a distal end view of the ring of FIG. 31;

FIG. 33 shows a needle tip assembly according to still anotherembodiment of the invention. The needle tip assembly is shown in aposition prior to installation onto the proximal end. The needle tip isshown in partial cross-section while the needle tip cap and the needlecap are shown in cross-section. Unlike the previous embodiments shown inFIGS. 8-32, this embodiment utilizes a ring which does not lock whenmoved to a position causing the inwardly projecting members to deflectinwardly. As such, the needle tip does not include projections whichwould engage with a recess in the ring;

FIG. 34 shows a needle tip assembly according to still anotherembodiment of the invention. The needle tip assembly is shown in aposition prior to installation onto the proximal end. The needle tip isshown in partial cross-section while the needle tip cap and the needlecap are shown in cross-section. Unlike the previous embodiments shown inFIGS. 8-32, this embodiment utilizes a ring which does not lock whenmoved to a position causing the inwardly projecting members to deflectinwardly;

FIG. 35 shows a needle tip assembly according to still anotherembodiment of the invention. The needle tip assembly is shown in aposition prior to installation onto the proximal end. The needle tip isshown in partial cross-section while the needle tip cap and the needlecap are shown in cross-section. Unlike the previous embodiments shown inFIGS. 8-32, this embodiment utilizes a ring which does not have atapered distal end and does not lock to the needle tip when moved to aposition causing the inwardly projecting members to deflect inwardly;

FIG. 36 shows a side view of a needle tip according to still anotherembodiment of the invention. The needle tip is shown in a position priorto installation onto the proximal end. Unlike the previous embodimentsshown in FIGS. 8-32, this embodiment utilizes an elastic ring and aslotted distal end portion on the needle tip. That way, when the ring ismoved towards the distal end, the ring causes the slotted distal end tocompress or deflect inwardly;

FIG. 37 shows a distal end view of a needle tip shown in FIG. 36;

FIG. 38 shows a side view of a needle tip of FIG. 36 with the needle tipbeing in a position after removal from the proximal end. The ring hasbeen moved towards the distal end causing the slotted distal end of theneedle tip to compress or deflect inwardly and thereby prevent itsre-installation;

FIG. 39 shows a side view of a needle tip according to still anotherembodiment of the invention. The needle tip is similar to that shown inthe embodiment of FIGS. 8-19 except that it utilizes mechanisms fortransferring torque from the needle tip cap to the needle tip. Thesemechanisms have the form of projections formed on the needle tip whichslidably engage with recesses formed within the needle tip cap;

FIG. 40 shows a side cross-section view of a needle tip cap which can beused with the needle tip shown in FIG. 39. The needle tip cap is similarto that shown in the embodiment of FIGS. 8-19 except that it utilizesmechanisms for transferring torque from the needle tip cap to the needletip. These mechanisms have the form of recesses formed within the needletip cap which slidably receive therein the projections formed on theneedle tip;

FIG. 41 shows a needle tip assembly according to still anotherembodiment of the invention. The needle tip assembly is shown in aposition after being installed onto the proximal end of the pen needleinjection device. The needle tip is shown in partial cross-section whilethe needle tip cap and the needle cap are shown in cross-section. Unlikethe previous embodiments shown in FIGS. 8-40, this embodiment utilizes aneedle tip cap that is slid over the proximal end of the pen needledevice and remains on the device during injection. Furthermore, the ringincludes a circumferential projection which acts to retain the needletip cap in the position shown in FIG. 41;

FIG. 42 shows the needle tip assembly of FIG. 41 after the needle tipcap is slid back to activate or move the ring to the locking positionand also expose the needle and needle cap;

FIG. 43 shows the needle tip assembly of FIG. 42 after the needle cap isremoved. As is shown in FIG. 43, the needle is now exposed and the penneedle device can now be used for injection;

FIG. 44 shows the needle tip assembly of FIG. 43 after the needle tipcap is moved back to the original position shown in FIG. 41. As is shownin FIG. 44, the needle is now covered or protected by the needle tipcap;

FIG. 45 shows a needle tip assembly according to still anotherembodiment of the invention. The needle tip assembly is shown in aposition after being installed onto the proximal end of the pen needleinjection device. The needle tip is shown in partial cross-section whilethe needle tip cap and the needle cap are shown in cross-section. Thisembodiment is similar to the embodiment shown in FIGS. 41-44 except thatit also includes a spring which biases the needle tip cap towards theoriginal position;

FIG. 46 shows the pen needle device with a installed needle tipaccording to another non-limiting embodiment of the invention. Thisembodiment utilizes a ring which frictionally engages with projectionsof the needle tip without locking with the projections. In thisposition, the ring has been moved to the locked position which hascaused a plurality of inwardly deflecting members to engage the threadedproximal end of the pen needle device;

FIG. 47 shows a distal end view of another embodiment of a needle tipcap which can be used with one or more of the needle tip assemblyembodiments. The needle tip cap is of a two-piece construction whichpieces are connected one side with a living hinge and on the other sidewith a snap-together lock system;

FIG. 48 shows a side cross-section view of the needle tip cap shown inFIG. 47;

FIG. 49 shows another distal end view of the needle tip cap shown inFIG. 47 except that the two-piece construction is shown in the openposition;

FIG. 50 shows the proximal end of FIG. 1 along with a needle tipassembly according to another embodiment of the invention. The needletip assembly is similar to that shown in the prior art FIGS. 1-7 exceptthat the needle tip includes a rear cap member which is mounted to theneedle tip body via a living hinge. The needle tip cap also includes amechanism which allows the rear cap member to temporarily lock thereto.The rear cap, needle tip cap and the needle cap are shown incross-section;

FIG. 51 shows the needle tip assembly of FIG. 50 after the rear end capis unlocked from the needle tip cap and been deflected distally. In thisposition, the needle tip cap can then be removed in the manner shown inFIG. 4;

FIG. 52 shows the needle tip used in the embodiment shown in FIG. 50 andillustrates how the rear cap can be deflected via the living hinge to aposition prior to covering the distal end of the needle tip;

FIG. 53 shows the proximal end of FIG. 1 along with a needle tipassembly according to another embodiment of the invention. The needletip is similar to that shown in the prior art FIGS. 1-7 except that theneedle tip includes a needle cap member which is mounted to the needletip body via a living hinge. The needle cap also includes a mechanismwhich allows the needle cap member to temporarily lock to the needle tipbody. The needle cap is shown in cross-section;

FIG. 54 shows the needle tip assembly of FIG. 53 after the needle cap isunlocked from the needle tip and been deflected distally. In thisposition, the needle tip can be used to perform an injection;

FIG. 55 shows one non-limiting way in which a plurality of needle tipassemblies of either the prior art variety or those of the inventiondescribed herein can be packaged in a housing. The housing alsofunctions as a tool for installing one needle tip assembly at a timeonto the end of a pen needle;

FIG. 56 shows the housing after one of the needle tip assemblies hasbeen installed onto the end of a pen needle; and

FIG. 57 shows the housing after the user advances a push-button to movethe needle tip assemblies to a position that readies it for installinganother of the needle tip assemblies onto the end of a pen needle.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the drawings and first to FIGS. 8-19 which shows afirst embodiment of a needle tip assembly. The needle tip assemblyincludes a needle tip cap 30 having various generally cylindricalportions with different diameters, a needle cap 40, and a needle tip 50.The proximal end 30 a of the needle tip cap 30 is closed while thedistal end includes a circumferential flange 30 b. The proximal end 40 aof the needle cap 40 is closed while the distal end includes acircumferential flange 40 b. The proximal end of the needle tip 50includes a needle N while the distal end includes an opening which issized to allow the needle tip 50 to be mounted to the threaded proximalend 2 of the pen needle device 1. In order to ensure that the needle tip50 is prevented from being re-installed onto the proximal end 2, theneedle tip 50 utilizes a ring 60 which can move axially from an initialposition (see FIG. 9) to a second position (see FIG. 10) which causesone or more inwardly deflecting members 50 a and 50 b to deflect inwardsby an amount which is sufficient to prevent the needle tip 50 (afterbeing removed) from being re-installed onto the proximal end 2. As canbe seen in FIG. 8, prior the needle tip assembly being installed ontothe threaded proximal end 2, the one or more inwardly deflecting members50 a and 50 b are bent outwardly or deflected outwardly by an amountwhich is sufficient to allow the needle tip 50 to be installed onto theproximal end 2 in the conventional manner, i.e., by axially sliding iton or by threading it on.

As can be seen in FIG. 9, the needle tip assembly can be installed ontothe threaded proximal end 2 without activating the re-use preventionmechanism, i.e., without causing the ring 60 to move axially to thelocked position. Accordingly, in the position shown in FIG. 9, the oneor more inwardly deflecting members 50 a and 50 b are still bentoutwardly or deflected outwardly by an amount which is sufficient toallow the needle tip 50 to be installed onto the proximal end 2 in theconventional manner. Furthermore, while the ring 60 is in the positionshown in FIG. 9, the needle tip assembly can be removed in theconventional way by, e.g., unthreading it off of the threaded end 2.

As can be seen in FIG. 10, after the needle tip assembly is installedonto the threaded proximal end 2 (as shown in FIG. 9), the needle tipcap 30 can be further moved axially in the distal direction (asindicated by the arrow in FIG. 10) to the point that it activates there-use prevention system or mechanism, i.e., it causes the ring 60 tomove axially in the distal direction until it assumes the lockedposition. The locked position is characterized by engagement between theprojections of the one or more inwardly deflecting members 50 a and 50 band the inner circumferential recess of the ring 60. Accordingly, in theposition shown in FIG. 10, the one or more inwardly deflecting members50 a and 50 b have been deflected inwardly so that they are now biasedagainst the proximal end 2 and frictionally engage the threads thereofwhen the needle tip 50 is unthreaded. Furthermore, while the ring 60 isin the position shown in FIG. 10, the needle tip assembly can beremoved, e.g., in the conventional way by unthreading it off of thethreaded end 2, but, unlike the prior art, cannot thereafter bereinstalled.

As can be seen in FIG. 11, once the needle tip assembly is installed(FIG. 9) and the re-use prevention system activated (FIG. 10), theneedle tip cap 30 can be removed by sliding it off axially. Then, asshown in FIG. 12, the needle cap 40 can be removed. FIG. 13 shows thepen needle device with the installed needle tip 50 in a position that isready for injection. Again, in this position, the ring 60 has been movedto the locked position which has caused a plurality of inwardlydeflecting members 50 a and 50 b to frictionally engage the threadedproximal end 2 of the pen needle device 1.

As can be seen in FIG. 14, once the pen needle device with the installedneedle tip assembly has been used to perform an injection, the needletip 50 can be removed in the following ways: one could simply grip theneedle tip 50 in the area of the ring 60 and unthread it from thethreaded proximal end 2. This is risky, of course, because the user canbe inadvertently be pricked by the exposed needle N; one couldre-install the needle cap 40 and then grip the needle tip 50 in the areaof the ring 60 and unthread it from the threaded proximal end 2; onecould re-install both the needle cap 40 and the needle tip cap 30, andthen grip the needle tip cap 30 in the area just in front of the flange30 b and thereafter unthread the entire needle tip assembly therebycausing the needle tip 50 to become unthreaded from the threadedproximal end 2; and one could re-install only the needle tip cap 30, andthen grip the needle tip cap 30 in the area just in front of the flange30 b and thereafter unthread the needle tip assembly (without the cap40) thereby causing the needle tip 50 to become unthreaded from thethreaded proximal end 2. All of these ways are contemplated by theinvention, but the first way is the least desirable.

As is evident from FIG. 14, once the needle tip 50 is removed from thethreaded proximal end 2 (and because the ring 60 has been moved to thelocked position), the plurality of inwardly deflecting members 50 a and50 b are caused to move inwardly to the point that they will not permit(i.e., they will interfere with) re-installation of the needle tip 50back onto the threaded proximal end 2 of the pen needle device 1. Thisis evident from FIG. 15 which shows how the plurality of inwardlydeflecting members 50 a and 50 b have been moved inwardly to the pointthat they will not permit (i.e., they will interfere with)re-installation of the needle tip 50 back onto the threaded proximal end2 of the pen needle device 1 owing to the fact that they effectivelyreduce the diameter of the distal opening of the needle tip 50.

As is evident from FIGS. 16 and 17, the needle cap 40 has a closedproximal end 40 a, an open distal end having a circumferential flange 40b, a distal opening 40 c sized to frictionally engage with a hub portionof the needle tip 50, and a tapered portion 40 d which is sized tosafely receive therein the needle N. Of course, the needle cap 40 canhave any desired configuration provided that it functions for itsintended purpose, and can even be dispensed with out leaving the scopeof the invention.

As is evident from FIGS. 18 and 19, the needle tip cap 30 has a closedproximal end 30 a, an open distal end having a circumferential flange 30b, a distal opening 30 c sized to receive therein the ring 60, ashoulder 30 c which engages with a distal end of the ring 60 so as tocause the ring 60 to move to the locked position, a generallycircumferential surface 30 e which is sized to frictionally engage withan outer surface of the needle tip 50 so as to cause it to rotaterelative to the proximal end 2, and a tapered and/or stepped portion 30f which is sized to safely receive therein the needle N and the needlecap 40. Of course, the needle tip cap 30 can have any desiredconfiguration provided that it functions for its intended purpose, andcan even be dispensed with out leaving the scope of the invention. Inthe later case, only the needle cap 40 (or even one of the type shown inFIGS. 53 and 54) would need to be utilized (for safety reasons) and theuser could activate the re-use prevention system by gripping the ring 60and sliding it distally until it assumes the locked position.

FIGS. 20-28 shows a second embodiment of a needle tip assembly. Theneedle tip assembly includes a needle tip cap 30 having variousgenerally cylindrical portions with different diameters, a needle cap40, and a needle tip 50′. As the needle tip cap 30, the needle cap 40,and the ring 60 of the instant embodiment are essentially identical tothose used in the previous embodiment, they have been accorded the samereference numerals. The proximal end 30 a of the needle tip cap 30 isclosed while the distal end includes a circumferential flange 30 b.Similarly, the proximal end 40 a of the needle cap 40 is closed whilethe distal end includes a circumferential flange 40 b. The proximal endof the needle tip 50′ includes a needle N while the distal end includesan opening which is sized to allow the needle tip 50′ to be mounted tothe threaded proximal end 2 of the pen needle device 1. In order toensure that the needle tip 50′ is prevented from being re-installed ontothe proximal end 2, the needle tip 50′ utilizes a ring 60 which can moveaxially from an initial position (see FIG. 21) to a second position (seeFIG. 22) which causes one or more inwardly deflecting members 50′a and50′b to deflect inwards by an amount which is sufficient to prevent theneedle tip 50′ (after being removed) from being re-installed onto theproximal end 2. As can be seen in FIG. 20, prior the needle tip assemblybeing installed onto the threaded proximal end 2, the one or moreinwardly deflecting members 50′a and 50′b are bent outwardly ordeflected outwardly by an amount which is sufficient to allow the needletip 50′ to be installed onto the proximal end 2 in the conventionalmanner, i.e., by axially sliding it on or by threading it on.

As can be seen in FIG. 21, the needle tip assembly can be installed ontothe threaded proximal end 2 without activating the re-use preventionsystem or mechanism, i.e., without causing the ring 60 to move axiallyto the locked position. Accordingly, in the position shown in FIG. 21,the one or more inwardly deflecting members 50′a and 50′b are still bentoutwardly or deflected outwardly by an amount which is sufficient toallow the needle tip 50′ to be installed onto the proximal end 2.Furthermore, while the ring 60 is in the position shown in FIG. 21, theneedle tip assembly can be removed in the conventional way, e.g., byunthreading it off of the threaded end 2.

As can be seen in FIG. 22, after the needle tip assembly is installedonto the threaded proximal end 2 (as shown in FIG. 21), the needle tipcap 30 can be further moved axially in the distal direction (asindicated by the arrow in FIG. 22) to the point that it activates there-use prevention system or mechanism, i.e., it causes the ring 60 tomove axially in the distal direction until it assumes the lockedposition. The locked position is characterized by engagement between theprojections of the one or more inwardly deflecting members 50′ and 50′and the inner circumferential recess of the ring 60. Accordingly, in theposition shown in FIG. 22, the one or more inwardly deflecting members50′a and 50′b have been deflected inwardly so that they are now biasedagainst the proximal end 2 and frictionally engage the threads thereofwhen the needle tip 50′ is unthreaded. Furthermore, while the ring 60 isin the position shown in FIG. 22, the needle tip assembly can beremoved, e.g., in the conventional way by unthreading it off of thethreaded end 2, but, unlike the prior art, cannot thereafter bereinstalled.

As can be seen in FIG. 23, once the needle tip assembly is installed(FIG. 21) and the re-use prevention system activated (FIG. 22), theneedle tip cap 30 can be removed by sliding it off axially. Then, asshown in FIG. 24, the needle cap 40 can also be removed axially. FIG. 25shows the pen needle device with the installed needle tip 50′ in aposition that is ready for injection. Again, in this position, the ring60 has been moved to the locked position which has caused a plurality ofinwardly deflecting members 50′a and 50′b to frictionally engage thethreaded proximal end 2 of the pen needle device 1.

As can be seen in FIGS. 26 and 27, once the pen needle device with theinstalled needle tip assembly has been used to perform an injection, theneedle tip 50′ can be removed in the following ways: one could simplygrip the needle tip 50′ in the area of the ring 60 and unthread it fromthe threaded proximal end 2. This is risky, of course, because the usercan be inadvertently be pricked by the exposed needle N; one couldre-install the needle cap 40 and then grip the needle tip 50′ in thearea of the ring 60 and unthread it from the threaded proximal end 2;one could re-install both the needle cap 40 and the needle tip cap 30,and then grip the needle tip cap 30 in the area just in front of theflange 30 b and thereafter unthread the entire needle tip assemblythereby causing the needle tip 50′ to become unthreaded from thethreaded proximal end 2; and one could re-install only the needle tipcap 30, and then grip the needle tip cap 30 in the area just in front ofthe flange 30 b and thereafter unthread the needle tip assembly (withoutthe cap 40) thereby causing the needle tip 50′ to become unthreaded fromthe threaded proximal end 2. As was the case in the previous embodiment,all of these ways are contemplated by the invention for this embodiment,with, however, the first way being the least desirable.

As is evident from FIG. 28, once the needle tip 50′ is removed from thethreaded proximal end 2 (and because the ring 60 has been moved to thelocked position), the plurality of inwardly deflecting members 50′a and50′b are caused to move inwardly to the point that they will not permit(i.e., they will interfere with) re-installation of the needle tip 50′back onto the threaded proximal end 2 of the pen needle device 1. Thisis evident from FIG. 28 which shows how the plurality of inwardlydeflecting members 50′a and 50′b have been moved inwardly to the pointthat they will not permit (i.e., they will interfere with)re-installation of the needle tip 50′ back onto the threaded proximalend 2 of the pen needle device 1 owing to the fact that they effectivelyreduce the diameter of the distal opening of the needle tip 50′. As isevident from comparing FIGS. 28 and 15, the needle tip 50′ differs fromthe needle tip 50 in that it does not utilize any internal threads inthe body of the needle tip 50′ (i.e., the distal opening which receivestherein the threaded proximal end 2 is generally cylindrical and smooth)and with regard to the shape of the projections which extend inwardlyfrom the members 50 a/50′a and 50 b/50′b. That is, the projections whichextend inwardly from the members 50 a and 50 b have a generally bluntend or rectangular-shaped cross-section whereas the projections whichextend inwardly from the members 50′a and 50′b have a generally taperedend or triangular-shaped cross-section so as to threadably engage withthe threads of the proximal end 2.

Although not shown, the embodiment shown in FIGS. 20-28 can instead,like the previous embodiment, utilize the needle tip cap shown in FIGS.47-49. Of course, the needle tip cap 30 can have any desiredconfiguration provided that it functions for its intended purpose, andcan even be dispensed with out leaving the scope of the invention. Inthe later case, only the needle cap 40 (or even one of the type shown inFIGS. 53 and 54) would need to be utilized (for safety reasons) and theuser could activate the re-use prevention system by gripping the ring 60and sliding it distally until it assumes the locked position.

FIGS. 29 and 30 show an optional needle tip 50″ which can be used withany of the embodiments disclosed herein. For purposes of clarity, thering 60 has been removed. Unlike the previous embodiments which utilizetwo oppositely arranged inwardly deflecting members 50 a/50′a and 50b/50′b which are caused to move inwardly by the ring 60, this embodimentutilizes four equally angularly spaced members 50″a, 50 ^(II)b, 50″c and50″d, which can be moved inwardly by the ring 60 to the point that theywill not permit (i.e., they will interfere with) re-installation of theneedle tip 50″ back onto the threaded proximal end 2 of the pen needledevice 1 owing to the fact that they effectively reduce the diameter ofthe distal opening of the needle tip 50″. Although the members 50″a, 50^(II)b, 50″c and 50″d are shown deflected inwardly (for purposes ofclarity), of course this would not occur until the ring 60 has beenmoved to the locked position. The needle tip 50″, like the secondembodiment, does not utilize any internal threads in the body of theneedle tip 50″ (i.e., the distal opening which receives therein thethreaded proximal end 2 is generally cylindrical and smooth) andutilizes projections P which extend inwardly from the members 50″a, 50^(II)b, 50″c and 50″d and have a generally tapered end ortriangular-shaped cross-section so as to threadably engage with thethreads of the proximal end 2. The projections P can extend all the wayacross the width of each of the members 50″a, 50 ^(II)b, 50″c and 50″d(as shown in FIG. 29) or they have other forms such as ones which areshorter than the width of the members 50″a, 50 ^(II)b, 50″c and 50″d.The projections P may even have the form of centrally disposed circularor rounded projections. Other configurations may also be utilizedprovided they are capable of locking with an/or frictionally engagingwith the ring 60.

As is evident from FIGS. 31 and 32, the ring 60 which can be used in theprevious embodiments is generally cylindrical and has a proximal end 60d which engages the shoulder 30 c of the needle tip cap 30, a distal endhaving a tapered inner surface 60 c configured to facilitate slidingover the deflecting members 50 a/50 b or 50′a/50′b or 50″a/50^(II)b/50″c//50″d, a circumferential recess 60 a sized and configured toreceive therein the projections P of the members 50 a/50 b or 50′a/50′bor 50″a/50 ^(II)b/50″c//50″d, and an inner cylindrical surface 60 bwhich is sized to slide over the needle tip body. Of course, the ring 60can have any desired configuration provided that it functions for itsintended purpose.

FIG. 33 shows still another embodiment of a needle tip assembly. Theneedle tip assembly includes a needle tip cap 30 having variousgenerally cylindrical portions with different diameters, a needle cap40, and a needle tip 50 ^(III). As the needle tip cap 30 and the needlecap 40 of the instant embodiment are essentially identical to those usedin the previous embodiment, they have been accorded the same referencenumerals. In this embodiment also, the proximal end 30 a of the needletip cap 30 is closed while the distal end includes a circumferentialflange 30 b. Similarly, the proximal end 40 a of the needle cap 40 isclosed while the distal end includes a circumferential flange 40 b. Theproximal end of the needle tip 50 ^(III) includes a needle N while thedistal end includes an opening which is sized to allow the needle tip 50^(III) to be mounted to the threaded proximal end 2 of the pen needledevice 1. In order to ensure that the needle tip 50 ^(III) is preventedfrom being re-installed onto the proximal end 2, the needle tip 50^(III) utilizes a ring 60′ which can move axially from an initialposition (similar to the position shown in FIG. 21) to a second position(similar to the position shown in FIG. 22) which causes the fourinwardly deflecting members 50 ^(III)a, 50 ^(III)c, 50 ^(III)d and 50^(III)d to deflect inwards by an amount which is sufficient to preventthe needle tip 50 ^(III) (after being removed) from being re-installedonto the proximal end 2. As can be seen in FIG. 33, prior to the needletip assembly being installed onto the threaded proximal end 2 (not shownin FIG. 33), the four inwardly deflecting members 50 ^(III)a, 50^(III)b, 50 ^(III)c and 50 ^(III)d are bent outwardly or deflectedoutwardly by an amount which is sufficient to allow the needle tip 50^(III) to be installed onto the proximal end 2 in the conventionalmanner, i.e., by axially sliding it on or by threading it on.

In a manner similar to that shown FIG. 21, the needle tip assembly ofFIG. 33 can be installed onto the threaded proximal end 2 withoutactivating the re-use prevention system or mechanism, i.e., withoutcausing the ring 60′ to move axially to the second or activatedposition. Accordingly, in the position shown in FIG. 33, the one or moreinwardly deflecting members 50 ^(III)a, 50 ^(III)b, 50 ^(III)c and 50^(III)d are still bent outwardly or deflected outwardly by an amountwhich is sufficient to allow the needle tip 50 ^(III) to be installedonto the proximal end 2. Furthermore, while the ring 60′ is in theposition shown in FIG. 33, the needle tip assembly can be removed in theconventional way, e.g., by unthreading it off of the threaded end 2.

In the same way as was shown in FIG. 22, after the needle tip assemblyshown in FIG. 33 is installed onto the threaded proximal end 2 (similarto that shown in FIG. 21), the needle tip cap 30 can be further movedaxially in the distal direction (as indicated by the arrow in FIG. 22)to the point that it activates the re-use prevention system ormechanism, i.e., it causes the ring 60′ to move axially in the distaldirection until it assumes the second or activated position. Unlike theprevious embodiments which provide for a locking position, i.e.,characterized by engagement between the projections of the inwardlydeflecting members and the inner circumferential recess of the ring,this embodiment utilizes no projections on the members 50 ^(III)a, 50^(III)b, 50 ^(III)c and 50 ^(III)d and does not therefore utilize therecess for receiving the same on the ring 60′. Instead, the ring 60′merely frictionally engages with the outer surfaces of the members 50^(III)a, 50 ^(III)b, 50 ^(III)c and 50 ^(III)d when it is moved to thesecond or activated position. In order to ensure that the ring 60′ doesnot move back to the original position (after being moved to the secondposition), the inner circumferential surface of the ring 60′ and theouter surface of the members 50 ^(III), 50 ^(III)b, 50 ^(III)c and 50^(III)d can be provided with high friction surfaces such as e.g., aknurl, a high friction coating, etc. Although not shown, when the ring60′ is moved to the second or activated position, the inwardlydeflecting members 50 ^(III)a, 50 ^(III)b, 50 ^(III)c and 50 ^(III)dwill be deflected inwardly (as was the case in the previous embodiments)so that they will biased against the proximal end 2 and frictionallyengage the threads thereof when the needle tip 50 ^(III) is unthreaded.

As was the case in the previous embodiments, once the needle tipassembly shown in FIG. 33 is installed and the re-use prevention systemactivated, the needle tip cap 30 can be removed by sliding it offaxially. Then, the needle cap 40 can also be removed axially. Once thepen needle device with the installed needle tip assembly has been usedto perform an injection, the needle tip 50 ^(III) can be removed in thefollowing ways: one could simply grip the needle tip 50 ^(III) in thearea of the ring 60′ and unthread it from the threaded proximal end 2.This is risky, of course, because the user can be inadvertently bepricked by the exposed needle N; one could re-install the needle cap 40and then grip the needle tip 50 ^(III) in the area of the ring 60′ andunthread it from the threaded proximal end 2; one could re-install boththe needle cap 40 and the needle tip cap 30, and then grip the needletip cap 30 in the area just in front of the flange 30 b and thereafterunthread the entire needle tip assembly thereby causing the needle tip50 ^(III) to become unthreaded from the threaded proximal end 2; and onecould re-install only the needle tip cap 30, and then grip the needletip cap 30 in the area just in front of the flange 30 b and thereafterunthread the needle tip assembly (without the cap 40) thereby causingthe needle tip 50 ^(III) to become unthreaded from the threaded proximalend 2. As was the case in the previous embodiments, all of these waysare contemplated by the invention for this embodiment, with, however,the first way being the least desirable.

As was the case in the embodiment shown in FIGS. 20-28, once the needletip 50 ^(III) is removed from the threaded proximal end 2 (and becausethe ring 60′ has been moved to the activated position), the plurality ofinwardly deflecting members 50 ^(III)a, 50 ^(III)b, 50 ^(III) and 50^(III)d are caused to move inwardly to the point that they will notpermit (i.e., they will interfere with) re-installation of the needletip 50 ^(III) back onto the threaded proximal end 2 of the pen needledevice 1. This occurs in substantially the same way as was shown in FIG.28 which shows how the plurality of inwardly deflecting members havebeen moved inwardly to the point that they will not permit (i.e., theywill interfere with) re-installation of the needle tip 50 ^(III) backonto the threaded proximal end 2 of the pen needle device 1 owing to thefact that they effectively reduce the diameter of the distal opening ofthe needle tip 50 ^(III).

Although not shown, the embodiment shown in FIG. 33 can, like theprevious embodiments, utilize the needle tip cap shown in FIGS. 47-49instead of the needle tip cap 30 shown in FIG. 33. Of course, the needletip cap 30 can also have any desired configuration provided that itfunctions for its intended purpose, and can even be dispensed with outleaving the scope of the invention. In the later case, only the needlecap 40 (or even one of the type shown in FIGS. 53 and 54) would need tobe utilized (for safety reasons) and the user could activate the re-useprevention system by gripping the ring 60′ and sliding it distally untilit assumes the activated position.

FIG. 34 shows still another embodiment of a needle tip assembly. Theneedle tip assembly includes a needle tip cap 30 having variousgenerally cylindrical portions with different diameters, a needle cap40, and a needle tip 50 ^(II) of the type shown in FIGS. 29 and 30. Asthe needle tip cap 30 and the needle cap 40 of the instant embodimentare essentially identical to those used in previous embodiments, theyhave been accorded the same reference numerals. In this embodiment also,the proximal end 30 a of the needle tip cap 30 is closed while thedistal end includes a circumferential flange 30 b. Similarly, theproximal end 40 a of the needle cap 40 is closed while the distal endincludes a circumferential flange 40 b. The proximal end of the needletip 50 ^(II) includes a needle N while the distal end includes anopening which is sized to allow the needle tip 50 ^(II) to be mounted tothe threaded proximal end 2 of the pen needle device 1. In order toensure that the needle tip 50 ^(II) is prevented from being re-installedonto the proximal end 2, the needle tip 50 ^(II) utilizes a ring 60′which can move axially from an initial position (similar to the positionshown in FIG. 21) to a second position (similar to the position shown inFIG. 22) which causes the four inwardly deflecting members 50 ^(II)a, 50^(II)a, 50 ^(II)b, 50 ^(II)c and 50 ^(II)d to deflect inwards by anamount which is sufficient to prevent the needle tip 50 ^(II) (afterbeing removed) from being re-installed onto the proximal end 2. As canbe seen in FIG. 34, prior to the needle tip assembly being installedonto the threaded proximal end 2 (not shown in FIG. 34), the fourinwardly deflecting members 50 ^(II)a, 50 ^(II)b, 50 ^(II)c and 50^(II)d are bent outwardly or deflected outwardly by an amount which issufficient to allow the needle tip 50 ^(II) to be installed onto theproximal end 2 in the conventional manner, i.e., by axially sliding iton or by threading it on.

In a manner similar to that shown FIG. 21, the needle tip assembly ofFIG. 34 can be installed onto the threaded proximal end 2 withoutactivating the re-use prevention system or mechanism, i.e., withoutcausing the ring 60′ to move axially to the second or activatedposition. Accordingly, in the position shown in FIG. 34, the one or moreinwardly deflecting members 50 ^(II)a, 50 ^(II)b, 50 ^(II)c and 50^(II)d are still bent outwardly or deflected outwardly by an amountwhich is sufficient to allow the needle tip 50 ^(II) to be installedonto the proximal end 2. Furthermore, while the ring 60′ is in theposition shown in FIG. 34, the needle tip assembly can be removed in theconventional way, e.g., by unthreading it off of the threaded end 2.

In the same way as was shown in FIG. 22, after the needle tip assemblyshown in FIG. 34 is installed onto the threaded proximal end 2 (similarto that shown in FIG. 21), the needle tip cap 30 can be further movedaxially in the distal direction (as indicated by the arrow in FIG. 22)to the point that it activates the re-use prevention system ormechanism, i.e., it causes the ring 60′ to move axially in the distaldirection until it assumes the second or activated position. Unlike theprevious embodiments which provide for a locking position, i.e.,characterized by engagement between the projections of the inwardlydeflecting members and the inner circumferential recess of the ring,this embodiment utilizes projections on the members 50 ^(II)a, 50^(II)b, 50 ^(II)c and 50 ^(II)d, but does not utilize the recess forreceiving the same on the ring 60′. Instead, the ring 60′ merelyfrictionally engages with the projections of the members 50 ^(II)a, 50^(II)b, 50″c and 50 ^(II)d (thereby causing the members 50 ^(II)a, 50^(II)b, 50 ^(II)C and 50 ^(II)d to deflect inwardly to a greater extentthan would be the case without the projections) when it is moved to thesecond or activated position. In order to ensure that the ring 60′ doesnot move back to the original position (after being moved to the secondposition), the inner circumferential surface of the ring 60′ and theprojections of the members 50 ^(II)a, 50 ^(II)b, 50 ^(II)c and 50 ^(II)dcan be provided with high friction surfaces such as e.g., a knurl, ahigh friction coating, etc. Although not shown, when the ring 60′ ismoved to the second or activated position, the inwardly deflectingmembers 50 ^(II)a, 50 ^(II)b, 50 ^(II)c and 50 ^(II)d will be deflectedinwardly (as was the case in the previous embodiments) so that they willbiased against the proximal end 2 and frictionally engage the threadsthereof when the needle tip 50 ^(II) is unthreaded.

As was the case in the previous embodiments, once the needle tipassembly shown in FIG. 34 is installed and the re-use prevention systemactivated, the needle tip cap 30 can be removed by sliding it offaxially. Then, the needle cap 40 can also be removed axially. Once thepen needle device with the installed needle tip assembly of FIG. 34 hasbeen used to perform an injection, the needle tip 50 ^(II) can beremoved in the following ways: one could simply grip the needle tip 50^(II) in the area of the ring 60′ and unthread it from the threadedproximal end 2. This is risky, of course, because the user can beinadvertently be pricked by the exposed needle N; one could re-installthe needle cap 40 and then grip the needle tip 50 ^(II) in the area ofthe ring 60′ and unthread it from the threaded proximal end 2; one couldre-install both the needle cap 40 and the needle tip cap 30, and thengrip the needle tip cap 30 in the area just in front of the flange 30 band thereafter unthread the entire needle tip assembly thereby causingthe needle tip 50 ^(II) to become unthreaded from the threaded proximalend 2; and one could re-install only the needle tip cap 30, and thengrip the needle tip cap 30 in the area just in front of the flange 30 band thereafter unthread the needle tip assembly (without the cap 40)thereby causing the needle tip 50 ^(II) to become unthreaded from thethreaded proximal end 2. As was the case in the previous embodiments,all of these ways are contemplated by the invention for this embodiment,with, however, the first way being the least desirable.

As was the case in the embodiment shown in FIGS. 20-28, once the needletip 50 ^(II) is removed from the threaded proximal end 2 (and becausethe ring 60′ has been moved to the activated position), the plurality ofinwardly deflecting members 50 ^(II)a, 50 ^(II)b, 50 ^(II)c and 50^(II)d are caused to move inwardly to the point that they will notpermit (i.e., they will interfere with) re-installation of the needletip 50 ^(II) back onto the threaded proximal end 2 of the pen needledevice 1. This occurs in substantially the same way as was shown in FIG.28 which shows how the plurality of inwardly deflecting members havebeen moved inwardly to the point that they will not permit (i.e., theywill interfere with) re-installation of the needle tip 50 ^(II) backonto the threaded proximal end 2 of the pen needle device 1 owing to thefact that they effectively reduce the diameter of the distal opening ofthe needle tip 50 ^(II).

Although not shown, the embodiment shown in FIG. 34 can, like theprevious embodiments, utilize the needle tip cap shown in FIGS. 47-49instead of the needle tip cap 30 shown in FIG. 34. Of course, the needletip cap 30 can also have any desired configuration provided that itfunctions for its intended purpose, and can even be dispensed with outleaving the scope of the invention. In the later case, only the needlecap 40 (or even one of the type shown in FIGS. 53 and 54) would need tobe utilized (for safety reasons) and the user could activate the re-useprevention system by gripping the ring 60′ and sliding it distally untilit assumes the activated position.

FIG. 35 shows still another embodiment of a needle tip assembly. Theneedle tip assembly includes a needle tip cap 30 having variousgenerally cylindrical portions with different diameters, a needle cap40, and a needle tip 50 ^(III) of the type shown in FIG. 33. As theneedle tip cap 30 and the needle cap 40 of the instant embodiment areessentially identical to those used in the previous embodiments, theyhave been accorded the same reference numerals. In this embodiment also,the proximal end 30 a of the needle tip cap 30 is closed while thedistal end includes a circumferential flange 30 b. Similarly, theproximal end 40 a of the needle cap 40 is closed while the distal endincludes a circumferential flange 40 b. The proximal end of the needletip 50 ^(III) includes a needle N while the distal end includes anopening which is sized to allow the needle tip 50 ^(III) to be mountedto the threaded proximal end 2 of the pen needle device 1. In order toensure that the needle tip 50 ^(III) is prevented from beingre-installed onto the proximal end 2, the needle tip 50 ^(III) utilizesa ring 60″ which can move axially from an initial position (similar tothe position shown in FIG. 21) to a second position (similar to theposition shown in FIG. 22) which causes the four inwardly deflectingmembers 50 ^(III)a, 50 ^(III)b, 50 ^(III)c and 50 ^(III)d to deflectinwards by an amount which is sufficient to prevent the needle tip 50^(III) (after being removed) from being re-installed onto the proximalend 2. As can be seen in FIG. 35, prior to the needle tip assembly beinginstalled onto the threaded proximal end 2 (not shown in FIG. 35), thefour inwardly deflecting members 50 ^(III), 50 ^(III)b, 50 ^(III)c and50 ^(III)d are bent outwardly or deflected outwardly by an amount whichis sufficient to allow the needle tip 50 ^(III) to be installed onto theproximal end 2 in the conventional manner, i.e., by axially sliding iton or by threading it on.

In a manner similar to that shown FIG. 21, the needle tip assembly ofFIG. 35 can be installed onto the threaded proximal end 2 withoutactivating the re-use prevention system or mechanism, i.e., withoutcausing the ring 60″ to move axially to the second or activatedposition. Accordingly, in the position shown in FIG. 35, the one or moreinwardly deflecting members 50 ^(III)a, 50 ^(III)b, 50 ^(III)c and 50^(III)d are still bent outwardly or deflected outwardly by an amountwhich is sufficient to allow the needle tip 50 ^(III) to be installedonto the proximal end 2. Furthermore, while the ring 60″ is in theposition shown in FIG. 35, the needle tip assembly can be removed bye.g., sliding or threading it off of the threaded end 2.

In the same way as was shown in FIG. 22, after the needle tip assemblyshown in FIG. 35 is installed onto the threaded proximal end 2 (similarto that shown in FIG. 21), the needle tip cap 30 can be further movedaxially in the distal direction (as indicated by the arrow in FIG. 22)to the point that it activates the re-use prevention system ormechanism, i.e., it causes the ring 60″ to move axially in the distaldirection until it assumes the second or activated position. Unlike theprevious embodiments which provide for a locking position, i.e.,characterized by engagement between the projections of the inwardlydeflecting members and the inner circumferential recess of the ring,this embodiment utilizes no projections on the members 50 ^(III)a, 50^(III)b, 50 ^(III)c and 50 ^(III)d and does not therefore utilize therecess for receiving the same on the ring 60″. Furthermore, unlike theembodiment shown in FIG. 33, the ring 60″ of this embodiment utilizes noinner tapered section. Instead, the ring 60″ merely frictionally engageswith the outer surfaces of the members 50 ^(III), 50 ^(III)b, 50 ^(III)cand 50 ^(III)d when it is moved to the second or activated position. Inorder to ensure that the ring 60″ does not move back to the originalposition (after being moved to the second position), the innercircumferential surface of the ring 60″ and the outer surface of themembers 50 ^(III)a, 50 ^(III)b, 50 ^(III)c and 50 ^(III)d can beprovided with high friction surfaces such as e.g., a knurl, a highfriction coating, etc. Although not shown, when the ring 60″ is moved tothe second or activated position, the inwardly deflecting members 50^(III), 50 ^(III)b, 50 ^(III)c and 50 ^(III)d will be deflected inwardly(as was the case in the previous embodiments) so that they will biasedagainst the proximal end 2 and frictionally engage the threads thereofwhen the needle tip 50 ^(III) is unthreaded.

As was the case in the previous embodiments, once the needle tipassembly shown in FIG. 35 is installed and the re-use prevention systemactivated, the needle tip cap 30 can be removed by sliding it offaxially. Then, the needle cap 40 can also be removed axially. Once thepen needle device with the installed needle tip assembly has been usedto perform an injection, the needle tip 50 ^(III) can be removed in thefollowing ways: one could simply grip the needle tip 50 ^(III) in thearea of the ring 60″ and unthread it from the threaded proximal end 2.This is risky, of course, because the user can be inadvertently bepricked by the exposed needle N; one could re-install the needle cap 40and then grip the needle tip 50 ^(III) in the area of the ring 60″ andunthread it from the threaded proximal end 2; one could re-install boththe needle cap 40 and the needle tip cap 30, and then grip the needletip cap 30 in the area just in front of the flange 30 b and thereafterunthread the entire needle tip assembly thereby causing the needle tip50 ^(III) to become unthreaded from the threaded proximal end 2; and onecould re-install only the needle tip cap 30, and then grip the needletip cap 30 in the area just in front of the flange 30 b and thereafterunthread the needle tip assembly (without the cap 40) thereby causingthe needle tip 50 ^(III) to become unthreaded from the threaded proximalend 2. As was the case in the previous embodiments, all of these waysare contemplated by the invention for this embodiment, with, however,the first way being the least desirable.

As was the case in the embodiment shown in FIGS. 20-28, once the needletip 50 ^(III) is removed from the threaded proximal end 2 (and becausethe ring 60″ has been moved to the activated position), the plurality ofinwardly deflecting members 50 ^(III), 50 ^(III)b, 50 ^(III)c and 50^(III)d are caused to move inwardly to the point that they will notpermit (i.e., they will interfere with) re-installation of the needletip 50 ^(III) back onto the threaded proximal end 2 of the pen needledevice 1. This occurs in substantially the same way as was shown in FIG.28 which shows how the plurality of inwardly deflecting members havebeen moved inwardly to the point that they will not permit (i.e., theywill interfere with) re-installation of the needle tip 50 ^(III) backonto the threaded proximal end 2 of the pen needle device 1 owing to thefact that they effectively reduce the diameter of the distal opening ofthe needle tip 50 ^(III).

Although not shown, the embodiment shown in FIG. 35 can, like theprevious embodiments, utilize the needle tip cap shown in FIGS. 47-49instead of the needle tip cap 30 shown in FIG. 33. Of course, the needletip cap 30 can also have any desired configuration provided that itfunctions for its intended purpose, and can even be dispensed with outleaving the scope of the invention. In the later case, only the needlecap 40 (or even one of the type shown in FIGS. 53 and 54) would need tobe utilized (for safety reasons) and the user could activate the re-useprevention system by gripping the ring 60″ and sliding it distally untilit assumes the activated position.

FIGS. 36 and 37 show an optional needle tip 50 ^(IV) which can be usedwith any of the embodiments disclosed herein. Unlike the previousembodiments which utilize a essentially rigid or semi-rigid ring, thisembodiment utilizes an elastic-type ring 60 ^(III); that is a ring whichfunctions like an expanded rubber band that wants to contract. Indeed,the invention contemplates that the ring 60 ^(III) can be a rubber bandring or even a split spring metal ring which wants to contract but iskept expanded by virtue of being mounted to a portion of the body of theneedle tip 50 ^(IV) which prevents its contraction. Furthermore, unlikethe previous embodiments which utilize inwardly deflecting members whichare caused to move inwardly by the ring, this embodiment utilizes fourequally angularly spaced slots 50 ^(IV)a, 50 ^(IV)b, 50 ^(IV)c and 50^(IV)d, which weakens the distal end of the needle tip 50 ^(IV) to thepoint that when, the ring 60 ^(III) is moved over the slots 50 ^(IV)a,50 ^(IV)b, 50 ^(IV)c and 50 ^(IV)d, the distal end of the needle tip 50¹′ will deflect inwardly to the point that it will not permit (i.e., itwill interfere with) re-installation of the needle tip 50 ^(IV) backonto the threaded proximal end 2 of the pen needle device 1 owing to thefact that they effectively reduce the diameter of the distal opening ofthe needle tip 50 ^(IV). The needle tip 50 ^(IV), like the secondembodiment, does not utilize any internal threads in the body of theneedle tip 50 ^(IV) (i.e., the distal opening which receives therein thethreaded proximal end 2 is generally cylindrical and smooth).

As is evident from FIG. 38, once the needle tip 50 ^(IV) is removed fromthe threaded proximal end 2 (and because the ring 60 ^(III) has beenmoved to the activated position), the distal end of the needle tip 50^(VI) deflects inwardly to the point that it will not permit (i.e., willinterfere with) re-installation of the needle tip 50 ^(IV) back onto thethreaded proximal end 2 of the pen needle device 1. When this occurs,the distal end of the needle tip 50 ^(IV) effectively reduces thediameter of the distal opening of the needle tip 50 ^(IV).

FIGS. 39 and 40 show an optional needle tip se which can be used withany of the needle tip assembly embodiments disclosed herein. The ring 60can be, by way of non-limiting example, of the type described above inFIGS. 31 and 32. The needle tip 50 ^(V) can be, by way of non-limitingexample, of the type described above in FIGS. 29 and 30, except that itadditionally utilizes a plurality of e.g., equally angularly spaced,guide/engaging projections 50 ^(V)e which are sized and configured toslide within correspondingly placed guide/engaging recesses 30′garranged on the needle tip cap 30′. This embodiment similarly utilizesfour equally angularly spaced members 50 ^(II)a, 50 ^(II)b, 50 ^(V)c and50 ^(V)d, which can be moved inwardly by the ring 60 to the point thatthey will not permit (i.e., they will interfere with) re-installation ofthe needle tip 50 ^(V) back onto the threaded proximal end 2 of the penneedle device 1 owing to the fact that they effectively reduce thediameter of the distal opening of the needle tip 50 ^(V).

FIG. 40 shows a needle tip cap 30′ which can be used with the needle tip50 ^(V) shown in FIG. 39. The needle tip cap 30′ is similar to the capshown in FIGS. 18 and 19 except that it also utilizes e.g., equallyangularly spaced, guide/engaging recesses 30′g which are sized andconfigured to slidably receive therein correspondingly placedguide/engaging projections 50 ^(V)e arranged on the needle tip 50 ^(V).The needle tip cap 30′ has a closed proximal end 30′a, an open distalend having a circumferential flange 30′b, a distal opening 30′c sized toreceive therein the ring 60, a shoulder 30′c which engages with a distalend of the ring 60 so as to cause the ring 60 to move to the lockedposition, a generally circumferential surface 30′e which is sized toslide over an outer surface of the needle tip 50 ^(V) and allow forengagement between guide/engaging projections 50 ^(V)e andguide/engaging recesses 30′g. Of course, the needle tip cap 30′ can haveany desired configuration provided that it functions for its intendedpurpose.

FIGS. 41-44 show still another embodiment of a needle tip assembly. Theneedle tip assembly includes a needle tip cap 300 having a generallycylindrical configuration, a needle cap 40, and a needle tip 50 ^(II) ofthe type shown in FIGS. 29 and 30, and except that the ring 60 ^(IV) hasa different configuration. In this embodiment, the ring 60 ^(IV) isgenerally cylindrical and has a proximal end 60 ^(IV)d which engages theshoulder 300 c of the needle tip cap 300, a distal end having a taperedinner surface 60 ^(IV)c configured to facilitate sliding over thedeflecting members 50″a/50″b/50″c//50″d, a circumferential recess 60^(IV)a sized and configured to receive therein the projections P of themembers 50″a/50″b/50″c//50″d, and an inner cylindrical surface 60 ^(IV)bwhich is sized to slide over the needle tip body. Of course, the ring 60^(IV) can have any desired configuration provided that it functions forits intended purpose. Additionally, the ring 60 ^(IV) has a generallycircumferential proximal flange 60 ^(IV)d which prevents the needle tipcap 300 from sliding off the ring 60 ^(IV) V in the proximal direction.The ring 60 ^(IV) also has a generally circumferential retainingprojection 60 ^(IV)f which ensures that the needle tip cap 300 is ableto move the ring 60 ^(IV) in the distal direction so as to cause it tolock to the needle tip 50″. However, after the ring 60 ^(IV) becomeslocked to the needle tip 50″, the projection 60 ^(IV)f will not be ableto prevent further movement of the cap 300 and is, in fact, configuredto allow (upon exertion of a predetermined force) the inwardlyprojecting circumferential projection 300 e to pass over the projection60 ^(IV)f until the annular surface 300 c of the projection 300 eengages the proximal shoulder of the pen needle device 1. This is shownin FIG. 42. As the needle cap 40 of the instant embodiment isessentially identical to that used in the previous embodiment, it hasbeen accorded the same reference numeral. In this embodiment, theproximal end 300 a of the needle tip cap 300 is open (unlike theprevious embodiments) while the distal end is configured to slide overthe proximal portion of the device 1. Similarly, the proximal end 40 aof the needle cap 40 is closed while the distal end includes acircumferential flange 40 b. The proximal end of the needle tip 50 ^(II)includes a needle N while the distal end includes an opening which issized to allow the needle tip 50 ^(II) to be mounted to the threadedproximal end 2 of the pen needle device 1. In order to ensure that theneedle tip 50 ^(II) is prevented from being re-installed, onto theproximal end 2, the needle tip 50 ^(II) utilizes the ring 60 ^(IV) whichcan move axially from an initial position (shown in FIG. 41) to a secondor locked position (shown in FIG. 42) which causes the four inwardlydeflecting members 50 ^(II)a, 50 ^(II)b, 50 ^(II)c and 50 ^(II)d todeflect inwards by an amount which is sufficient to prevent the needletip 50 ^(II) (after being removed) from being re-installed onto theproximal end 2. As can be seen in FIG. 41, prior to activation, the fourinwardly deflecting members 50 ^(II)a, 50 ^(II)b, 50 ^(II)c and 50^(III)d are bent outwardly or deflected outwardly by an amount which issufficient to allow the needle tip 50 ^(II) to be installed onto theproximal end 2, i.e., by axially sliding it on or by threading it on.

As can be seen in FIG. 41, the needle tip assembly of FIG. 41 can beinstalled onto the threaded proximal end 2 without activating the re-useprevention system or mechanism, i.e., without causing the ring 60 ^(IV)to move axially to the second or activated position. Accordingly, in theposition shown in FIG. 41, the one or more inwardly deflecting members50 ^(II)a, 50 ^(II)b, 50 ^(II)c and 50 ^(II)d are still bent outwardlyor deflected outwardly by an amount which is sufficient to allow theneedle tip 50 ^(II) to be installed onto the proximal end 2.Furthermore, while the ring 60 ^(IV) is in the position shown in FIG.41, the needle tip assembly can be removed, e.g., by sliding it off ofthe threaded end 2.

As is evident from FIG. 42, after the needle tip assembly shown in FIG.41 is installed onto the threaded proximal end 2, the needle tip cap 300can be further moved axially in the distal direction (as indicated bythe arrow in FIG. 42) to the point that it activates the re-useprevention system or mechanism, i.e., it causes the ring 60 ^(IV) tomove axially in the distal direction until it assumes the second orlocked or activated position. Like many of the previous embodiments,locking occurs because of engagement between the projections of theinwardly deflecting members and the inner circumferential recess of thering 60 ^(IV). This locking engagement also ensures that the ring 60^(IV) does not move back to the original position (after being moved tothe second position) when the cap 300 is moved in the proximal directionto protect inadvertent contact with the needle N (see FIG. 44). As isevident from FIG. 42, when the ring 60 ^(IV) is moved to the second oractivated position, the inwardly deflecting members 50 ^(II)a, 50^(II)b, 50 ^(II)c and 50 ^(II)d will be deflected inwardly (as was thecase in the previous embodiments) so that they will biased against theproximal end 2 and frictionally engage the threads thereof when theneedle tip 50 ^(II) is unthreaded.

Once the needle tip assembly shown in FIG. 41 is installed and there-use prevention system activated (see FIG. 42), the needle tip cap 300can be, after being in the position allowing it to be used for injection(see FIG. 43), slid in the proximal direction (see FIG. 44), but, unlikethe previous embodiments, it is not removed. Then, the needle cap 40 canalso be removed axially (in a manner similar to the previousembodiments). Once the pen needle device with the installed needle tipassembly has been used to perform an injection, the needle tip 50 ^(II)can be removed in the following way: one could re-install the needle cap40 and then grip the needle tip cap 300 and slid it in the proximaldirection until it assumes the position shown in FIG. 44; or one couldsimply grip the needle tip cap 300 and slid it in the proximal directionuntil it assumes the position shown in FIG. 44 without re-installing theneedle cap 40. In either case, the user can then safely remove theentire needle tip assembly by either removing it axially or unthreadingit axially. Of course, once removed, the needle tip assembly will beprevented from being re-installed because of the configuration of thering 60 ^(IV) and 50″. As was the case in the previous embodiments, allof these ways are contemplated by the invention for this embodiment.

Although not shown, the embodiment shown in FIGS. 41-44 can, like theprevious embodiments, utilize a needle cap of the type shown in FIGS. 53and 54).

FIG. 45 shows a needle tip assembly according to still anotherembodiment of the invention. The needle tip assembly is substantiallysimilar to that shown in FIGS. 41-44 except that it utilizes a coilcompression spring S to bias the needle tip cap 300 in a proximaldirection, i.e., towards the original position.

FIG. 46 shows still another embodiment of a needle tip 50 ^(VI) whichcan be used in one or more of the herein disclosed embodiments. Theneedle tip 50 ^(VI) be utilized with a needle tip cap of the typesdisclosed herein or not with the former being preferred. A needle cap 40(not shown) can also be utilized. The needle tip 50 ^(VI) can besubstantially similar to the embodiment shown in FIGS. 29 and 30, exceptthat it also includes a circumferential retaining shoulder RS whichensures that the ring 60 ^(V) is axially retained on the body of theneedle tip 50 ^(VI). The proximal end of the needle tip 50 ^(VI)includes a needle N while the distal end includes an opening which issized to allow the needle tip 50 ^(VI) to be mounted to the threadedproximal end 2 of the pen needle device 1. In order to ensure that theneedle tip 50 ^(VI) is prevented from being re-installed onto theproximal end 2, the needle tip 50 ^(VI) utilizes a ring 60 ^(V) whichcan move axially from an initial position (similar to the position shownin FIG. 21) to a second or activated position (shown in FIG. 46) whichcauses the four inwardly deflecting members 50 ^(II)a, 50 ^(II)b, 50″cand 50″d to deflect inwards by an amount which is sufficient to preventthe needle tip 50 ^(VI) (after being removed) from being re-installedonto the proximal end 2. Although not shown, prior to the needle tipassembly being installed onto the threaded proximal end 2, the fourinwardly deflecting members 50 ^(VI)a, 50 ^(VI)b, 50 ^(VI)c and 50^(VI)d are bent outwardly or deflected outwardly by an amount which issufficient to allow the needle tip 50 ^(VI) to be installed onto theproximal end 2.

In the same way as was shown in FIG. 22, after the needle tip assemblyshown in FIG. 46 is installed onto the threaded proximal end 2, theneedle tip cap 30 (not shown) can be further moved axially in the distaldirection to the point that it activates the re-use prevention system ormechanism, i.e., it causes the ring 60 ^(V) to move axially in thedistal direction until it assumes the second or activated position shownin FIG. 46. Unlike the previous embodiments which provide for a lockingposition, i.e., characterized by engagement between the projections ofthe inwardly deflecting members and the inner circumferential recess ofthe ring, this embodiment utilizes projections on the members 50 ^(VI)a,50 ^(VI)b, 50 ^(VI)c and 50 ^(VI)d and a recess in the ring 60 ^(V) forreceiving the same, but does not provide for a locking engagementbetween these members. Instead, the inner recess of the ring 60 ^(V)merely frictionally engages with the projections of the members 50^(VI)a, 50 ^(VI)b, 50 ^(VI)c and 50 ^(VI)d when it is moved to thesecond or activated position. In order to ensure that the ring 60 ^(V)does not move back to the original position (after being moved to thesecond position), the inner circumferential surface of the ring 60 ^(V)and the outer surface of the members 50 ^(VI)a, 50 ^(VI)b, 50 ^(VI)c and50 ^(VI)d can be provided with high friction surfaces such as e.g., aknurl, a high friction coating, etc. As shown in FIG. 46, when the ring60 ^(V) is moved to the second or activated position, the inwardlydeflecting members 50 ^(VI)a, 50 ^(VI)b, 50 ^(VI)c and 50 ^(VI)d aredeflected inwardly (as was the case in the previous embodiments) so thatthey will biased against the proximal end 2 and frictionally engage thethreads thereof when the needle tip 50 ^(VI) is unthreaded.

Once the re-use prevention system is activated (as shown in FIG. 46),the needle tip cap 30 (not shown) can be removed by sliding it offaxially. Then, the needle cap 40 (not shown) can also be removedaxially. Once the pen needle device with the installed needle tipassembly has been used to perforin an injection, the needle tip 50 ^(VI)can be removed in the following ways: one could simply grip the needletip 50 ^(VI) in the area of the ring 60 ^(V) and unthread it from thethreaded proximal end 2. This is risky, of course, because the user canbe inadvertently be pricked by the exposed needle N; one couldre-install the needle cap 40 and then grip the needle tip 50 ^(VI) inthe area of the ring 60 ^(V) and unthread it from the threaded proximalend 2; one could re-install both the needle cap 40 and the needle tipcap 30, and then grip the needle tip cap 30 in the area just in front ofthe flange 30 b and thereafter unthread the entire needle tip assemblythereby causing the needle tip 50″ to become unthreaded from thethreaded proximal end 2; and one could re-install only the needle tipcap 30, and then grip the needle tip cap 30 in the area just in front ofthe flange 30 b and thereafter unthread the needle tip assembly (withoutthe cap 40) thereby causing the needle tip 50 ^(VI) to become unthreadedfrom the threaded proximal end 2. As was the case in the previousembodiments, all of these ways are contemplated by the invention forthis embodiment, with, however, the first way being the least desirable.

As was the case in, e.g., the embodiment shown in FIGS. 20-28, once theneedle tip 50 ^(VI) is removed from the threaded proximal end 2 (andbecause the ring 60 ^(V) has been moved to the activated position), theplurality of inwardly deflecting members 50 ^(VI)a, 50 ^(VI)b, 50 ^(VI)cand 50 ^(VI)d are caused to move inwardly to the point that they willnot permit (i.e., they will interfere with) re-installation of theneedle tip 50 ^(VI) back onto the threaded proximal end 2 of the penneedle device 1. This occurs in substantially the same way as was shownin FIG. 28 which shows how the plurality of inwardly deflecting membershave been moved inwardly to the point that they will not permit (i.e.,they will interfere with) re-installation of the needle tip 50 ^(VI)back onto the threaded proximal end 2 of the pen needle device 1 owingto the fact that they effectively reduce the diameter of the distalopening of the needle tip 50 ^(VI).

Although not shown, the embodiment shown in FIG. 46 can, like theprevious embodiments, utilize the needle tip cap shown in FIGS. 47-49instead of the needle tip cap 30. Of course, the needle tip cap 30 canalso have any desired configuration provided that it functions for itsintended purpose, and can even be dispensed with out leaving the scopeof the invention. In the later case, only the needle cap 40 (or even oneof the type shown in FIGS. 53 and 54) would need to be utilized (forsafety reasons) and the user could activate the re-use prevention systemby gripping the ring 60 ^(V) and sliding it distally until it assumesthe activated position.

FIGS. 47-49 show an optional needle tip cap 3000 which can be used inone or more of the embodiments described herein. The needle tip cap 3000can be similar to that shown in FIGS. 18 and 19 except that it utilize atwo-piece folding connectable construction instead of the simpleone-piece integral construction shown in FIGS. 18 and 19. In order toconnect the two parts 3000A and 3000B, the cap 3000 utilizes a livinghinge LH at one end and a lock system utilizing a lock member LM and alocking projection LP. This type of cap is advantageous because itallows the user to position the cap 3000 from the side instead of fromthe needle end. As a result, one can install the cap 3000 with a lowerrisk of being inadvertently punctured by the needle.

FIGS. 50-52 show another non-limiting embodiment of a needle tipassembly which can be installed onto the proximal end of pen needledevice 1. The needle tip assembly is similar to that shown in the priorart FIGS. 1-7 except that the needle tip 50 ^(VII) includes a rear endcap member EC which is mounted to the needle tip body via a living hingeLH′. The needle tip cap also includes a mechanism which allows the rearcap member EC to temporarily lock thereto. FIG. 51 shows the needle tipassembly of FIG. 50 after the rear end cap EC is unlocked from theneedle tip cap and been deflected distally. In this position, the needletip cap can then be removed in the manner shown in FIG. 4. FIG. 52 showsthe needle tip 50 ^(VII) used in the embodiment shown in FIG. 50 andillustrates how the rear cap EC can be deflected via the living hingeLH′ to a position prior to covering the distal end of the needle tip 50^(VII). The end cap EC can also be utilized in one or more of theembodiments disclosed herein.

FIG. 53 shows a needle tip assembly according to another embodiment ofthe invention. The needle tip is similar to that shown in the prior artFIGS. 1-7 except that the needle tip includes a needle cap member 40′which is mounted to the needle tip body via a living hinge LH″. Theneedle cap also includes a mechanism which allows the needle cap member40′ to temporarily lock to the needle tip body. FIG. 54 shows the needletip assembly of FIG. 53 after the needle cap 40′ is unlocked from theneedle tip and been deflected distally. In this position, the needle tipcan be used to perform an injection.

FIGS. 55-57 show one non-limiting way in which a plurality of needle tipassemblies of either the prior art variety shown in FIGS. 2-7 or thoseof the invention described herein can be packaged in a housing H. Thehousing H performs the function of storing a number of needle tipassemblies and also functions as a tool for installing one needle tipassembly at a time onto the end of a pen needle. The housing H can be agenerally cylindrical member with an open front end and a closed rearend. A plurality of spring retaining members RM can be arranged near thefront open end. These members RM normally extend inwardly to prevent theneedle tip assembly which is to be installed onto a pen needle frommoving back into the housing H. Once in the position shown in FIG. 55,the user can grip the housing H and use it to force it onto the penneedle end 1. Of course, the user will first remove the removablesealing material layer (not shown) which is typically adhesivelyarranged on the open end of the needle tip cap, e.g., 3. Once thehousing H is used to install one of the needle tip assemblies, the usercan either leave the housing in the position shown in FIG. 56. Then,when the user desires to install a fresh needle tip assembly on the penneedle end 1, the user can slide the push button PB in the direction ofthe open end of the housing H until the next needle tip assembly reachesthe position shown in FIG. 57. In this regard, the inwardly bent freeends of retaining members RM (a total of e.g., four, can be utilized)are designed to deflect outwardly in order to allow the next needle tipassembly to pass by. Installation can then occur in the same way as wasdescribed with regard to FIG. 55. Once, all of the needle tipassemblies, e.g., five, are utilized, the housing H can be discarded. Asis evident from FIGS. 55-57, the push-button slides within an elongatedslot SL formed in the side wall of the housing H and has an innerportion which is configured to engage and cause to move the needle tipassemblies arranged in series. Of course, the housing H can also haveother configurations and can house as few as two or more than fiveassemblies.

The pen needle device described above can also utilize one or morefeatures disclosed in the prior art documents expressly incorporated byreference herein. Furthermore, one or more of the various parts of theneedle tip assembly can preferably be made as one-piece structures bye.g., injection molding, when doing so reduces costs of manufacture.Non-limiting materials for most of the parts include synthetic resinssuch as those approved for syringes or other medical devices.Furthermore, the invention also contemplates that any or all disclosedfeatures of one embodiment may be used on other disclosed embodiments,to the extent such modifications function for their intended purpose.

It is noted that the foregoing examples have been provided merely forthe purpose of explanation and are in no way to be construed as limitingof the present invention. While the present invention has been describedwith reference to an exemplary embodiment, it is understood that thewords which have been used herein are words of description andillustration, rather than words of limitation. Changes may be made,within the purview of the appended claims, as presently stated and asamended, without departing from the scope and spirit of the presentinvention in its aspects. Although the present invention has beendescribed herein with reference to particular means, materials andembodiments, the present invention is not intended to be limited to theparticulars disclosed herein; rather, the present invention extends toall functionally equivalent structures, methods and uses, such as arewithin the scope of the appended claims.

1. A pre-loaded syringe or pen needle injection device tip assemblycomprising: a needle tip comprising a body and a needle having a firstpuncturing end projecting out beyond a forward end of the body and asecond puncturing end projecting into an interior space of the body; theinterior space of the body being sized and configured to receive thereinone end of the pre-loaded syringe or the pen needle injection device; agenerally cylindrical sidewall of the body including a slot orientedparallel to the needle; the second puncturing end being sized andconfigured to extend into the one end when the body is installed on theone end; and the needle tip being structured and arranged to beremovably connected to the one end of the pre-loaded syringe or the penneedle injection device.
 2. The assembly of claim 1, further comprisingat least one of an arrangement for preventing re-installation or re-useof the needle tip, the arrangement comprising a movable member having anaxial length that is less than an axial length of the body and that isaxially movable; a safety mechanism pivotally coupled to the needle tipvia a living hinge and being movable from a position spaced from andarranged on a side of a needle of the needle tip to a position coveringthe needle of the needle tip; and a safety cover non-removably andpivotally coupled to the needle tip and being movable from a positionspaced from and arranged on a side of the body to a position covering anopen rear end of the body.
 3. The assembly of claim 2, wherein thearrangement comprises one of: a ring which is movable from a firstposition to a second position; a ring which is axially movable.
 4. Theassembly of claim 2, wherein the arrangement comprises a locking memberwhich is movable from an unlocked position to a locked position.
 5. Theassembly of claim 2, wherein the movable member is axially moveble froma first position to a second position by a needle tip cover.
 6. Theassembly of claim 2, wherein the movable member is axially moveble froma first position to a second position, and wherein, when in the secondposition, the needle tip is prevented from being re-installed.
 7. Theassembly of claim 2, wherein the movable member comprises an elasticmember mounted to a body of the needle tip, wherein the elastic memberis moveble from a first position to a second position, and wherein, whenin the second position, the needle tip is prevented from beingre-installed.
 8. The assembly of claim 2, wherein the body comprises atleast one inwardly projecting member adapted to be deflected inwardly.9. The assembly of claim 8, wherein the at least one inwardly projectingmember is biased away from inward deflection.
 10. The assembly of claim8, further comprising a needle tip cover structured and arranged tofacilitate installation of the needle tip, and wherein the movablemember is a ring which is moveble from a first position to a secondposition causing inward deflection of the at least one inwardlyprojecting member.
 11. A needle tip assembly for a pre-loaded syringe ora pen needle injection device, the needle tip assembly comprising: abody comprising: an internal space; an integrally formed internalthread; and at least one of: integrally formed deflectable members;oppositely arranged members having projections; members havingprojections extending inwardly; a needle having one end extending outpast a front end of the body and another end extending into the internalspace; the space arranged in the body being sized and configured toreceive therein the proximal end of the pre-loaded syringe or the penneedle injection device; and the other end of the needle being sized andconfigured to puncture the proximal end when the needle tip is installedon the proximal end.
 12. The assembly of claim 11, further comprising asleeve that is movable between a first position and a second position,wherein, when in the second position, the user is prevented fromreinstalling the needle tip assembly onto the proximal end of at leastone of the pen needle injection device and the pre-loaded syringe. 13.The assembly of claim 12, further comprising a shield that is movablebetween a first position and a second position, wherein, when in thesecond position, a proximal end the shield extends out past the one endof the needle.
 14. The assembly of claim 11, further comprising a springand a shield that is movable between a first position and a secondposition, wherein, when in the second position, a proximal end theshield extends out past the one end of the needle.
 15. The assembly ofclaim 11, further comprising an end cap member that is movable between afirst position and a second position, wherein, when in the secondposition, a portion of the end cap member extends into the internalspace of the body and a portion of the end cap member extends out past adistal end of the body.
 16. The assembly of claim 11, further comprisinga rear end cap member that is movable between a first position and asecond position, wherein, when in the second position, the rear end capcovers a distal end of the body.
 17. The assembly of claim 11, furthercomprising a front end cap member that is movable between a firstposition and a second position, wherein, when in the second position,the front end cap covers the one end of the needle.
 18. A needle tipassembly for a pre-loaded syringe or a pen needle injection device, theneedle tip assembly comprising: a one-piece body comprising an internalthread; a needle comprising a first puncturing end projecting from thebody and a second puncturing end extending into a space arranged in thebody; the space arranged in the body being sized and configured toreceive therein one end of the pre-loaded syringe or the pen needleinjection device; a movably mounted sleeve; a movable shield; a springarranged within the movable shield; the second puncturing end beingsized and configured to extend into and puncture the one end when thebody is installed on the one end; and wherein, once used and removed,the needle tip assembly is prevented from being re-installed.
 19. Amethod of using the needle tip assembly of claim 18, the methodcomprising: installing the needle tip on a pre-loaded syringe or a penneedle injection device; using the needle tip for injection; andremoving the needle tip in a manner which prevents re-use of the needletip.
 20. A method of using the needle tip assembly of claim 1, themethod comprising: installing the needle tip on a pre-loaded syringe ora pen needle injection device; using the needle tip for injection; andremoving the needle tip in a manner which prevents re-use of the needletip.